Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Viral Antigens, Inc. — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

103 daysmedian FDA review time
208 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K964874HSV-1 ANTIGEN CONTROL SLIDESViral Antigens, Inc.1997-07-012080
K971101HSV-2 ANTIGEN CONTROL SLIDESViral Antigens, Inc.1997-07-01970
K964875CMV ANTIGEN CONTROL SLIDESViral Antigens, Inc.1997-03-181030
K964872VZV ANTIGEN CONTROL SLIDESViral Antigens, Inc.1997-03-181030
K964870RSV ANTIGEN CONTROL SLIDESViral Antigens, Inc.1997-03-181030
K903882VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGGViral Antigens, Inc.1990-12-041040

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda